N116 Unit 1 Lesson 3

study of medications

substance capable of producing a biologic response

drug given for the purpose of producing a therapeutic resposne

-A&P
-pathophysiology
-chemistry
-microbiology
-nursing process

branch of medicine concerned with prevention of disease and treatment of suffering

refers using medications to prevent disease and treat suffering

produced by a pharmaceutical manufacturer

agents produced by animal cells and microorganisms
-e.g. hormones, antibodies, vaccines

-Natural plant extracts
-Vitamins, minerals
-Dietary supplements

Require a dispensing order (prescription) from a qualified health care professional prior to patient receiving drug
-traditional medicines, biologics

-Health care provider can examine patient prior to ordering medication, ensuring that order is appropriate for patient and condition
-Dose and frequency of dispensed drug can be controlled
-Patient provided with education about drug including dosing, interactions, adverse effects

Drugs that can be obtained by patients without consultation with a health care provider
-Traditional medications, natural health products

-Usually have a high margin of safety and few adverse effects
-Patients can treat themselves for common conditions by following directions on packaging
-convenience

chemical, generic, trade names e.g.
Chemical: N-Acetly-para-acetylaminophenol
Generic: Acetamniophen
trade: Tylenol

-Herbal and dietary supplements are not drugs.
-Not subjected to same regulatory process
-Can cause side effects and interact with prescription and OTC drugs
-Monitoring through Health Canada food branch

-requires prescription and pharmacist dispensation
-All prescription drugs, Schedule F and G, narcotics

requires pharmacist dispensation

available at pharmacy or pharmacy area (OTC)

can be sold at any store, no professional supervision

-triplicate prescription, provincial monitoring
-narcotics, amphetamines, barbiturates, etc.

created to protect the public from drug misuse and provide mechanism for quality assurance for safety and efficacy

responsible for ensuring the safety and quality of drugs, biologics, and natural health products
-standard is set by Food and Drug Act and Regulations

-Federal authority that regulates pharmaceutical drugs
-Manufacturer must provide substantive evidence of a drug's safety, efficacy and quality, per Food and Drugs Act and Regulations, to TPD for approval
-TPD approval required for drug to be marketed in Canada

Parallel branch to TPD that regulates biologics and radiopharmaceuticals

-parallel branch to TPD that regulates natural health products
-Not all countries have such regulations OR have different regulations ie food vs drug

preclinical trials using cultured cells, living tissues and small animal models

Clinical Trial Application and testing
Phase 1: healthy subjects (evaluate safety of drug and possible adverse effects)
-Phase 2: small group of patients with target condition
-Phase 2 large group of patients with target condition

manufacturer completes New Drug Submission (NDS) to Health Canada
-Outlines test data obtained from clinical trials, indication, adverse effects, production and packaging

committee of drug experts reviews NDS to identify benefits and risks

Health Canada shares information about drug with health care providers and consumers

if approved, Health Canada issues a Drug Information Number (DIN) and a Notice of Compliance to manufacturer
-Both required for marketing drug

Health Canada continues to evaluate drug safety and efficacy through quality assurance processes

Health Canada monitors safety and effectiveness (how well it works) of drugs, devices and vaccines, called 'post-market surveillance'.